Patients with recurrent or metastatic platinum-refractory head and neck cancer experience less clinically significant quality of life deterioration when given nivolumab than chemotherapy

medwireNews: Nivolumab may delay quality of life (QoL) deterioration in patients with platinum-refractory recurrent or metastatic squamous cell carcinoma (SCC) of the head and neck compared with an investigator’s choice of treatment, research suggests.

The exploratory analysis of patient-reported outcomes (PROs) follows the earlier report from the CheckMate 141 trial demonstrating significantly longer overall survival and less frequent grade 3 or 4 adverse events with nivolumab than methotrexate, docetaxel or cetuximab, say Kevin Harrington, from the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust in London, UK, and co-workers.

“In view of the major unmet need in this population and the importance of maintaining or improving quality of life for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, these data support nivolumab as a new standard of care option in this setting”, they write in The Lancet Oncology.

Patients given nivolumab were free from clinically meaningful deterioration in the functional and symptom domains of the EORTC Quality of Life Questionnaire–Core 30 between baseline and week 15 of the study.

For patients using an investigator’s choice of agent, however, a 10-point or greater decrease in score occurred in 53% of the 15 domains, denoting clinically meaningful deterioration between baseline and week 15 for measures such as fatigue, dyspnoea and appetite loss.

Similarly, responses to the EORTC head and neck cancer-specific module showed clinically meaningful worsening in none of the 18 domains for the nivolumab-treated patients but 44% of the domains for the chemotherapy group patients.

And at weeks 9 and 15, nivolumab-treated patients showed significant and clinically meaningful differences compared with the chemotherapy-treated counterparts on these two questionnaires for role and social functioning, fatigue, dyspnoea, appetite loss, and pain and sensory issues.

Furthermore, the nivolumab patients experienced a 7.3-point adjusted mean change on the three-level European Quality of Life–5 Dimensions visual analogue scale, indicating a clinically meaningful improvement in health status and function, whereas the chemotherapy group had a –7.8 change indicating clinically meaningful deterioration.

Over the three questionnaires, nivolumab was associated with a significantly longer time to deterioration than chemotherapy in 37% of the 35 domains, the researchers summarise.

Susanne Singer, from University Medical Centre Mainz in Germany, applauds the investigators in an accompanying comment for publishing their core QoL results alongside their main findings and reporting their data analysis in a “timely manner”.

“Future trials should take this as an example and further develop the methodology for analysis of PROs”, she recommends.

However, the commentator notes that the research was conducted before the updated version of the EORTC head and neck cancer-specific questionnaire that now assesses skin problems associated with nivolumab, such as rash and pruritus, was available. “Problems with skin could not be measured in this trial, though the toxicity profile suggests there might be more problems after nivolumab than after investigator's choice”, Susanne Singer says.

The commentator also highlights the drawbacks of the open-label trial design and exploratory status of the PRO findings, and the risk of differential dropout between patients with advanced disease who have good and poor QoL, observing that CheckMate 141 patients with poorer QoL were lost to follow-up sooner than those who continued with treatment.

Nevertheless, Susanne Singer says the trial “offers valuable insight into the potential effects of nivolumab on certain QoL domains in patients with advanced head and neck cancer who are reasonably fit”, including issues that patients have previously described as important, such as worrying, swallowing and talking.